Strengths, challenges, and strategies for implementing pragmatic multicenter randomized controlled trials (RCTs): example of the Personalized Citizen Assistance for Social Participation (APIC) trial.

Background: Randomized controlled trials (RCTs) are rigorous scientific research designs for evaluating intervention effectiveness. However, implementing RCTs in a real-world context is challenging. To develop strategies to improve its application, it is essential to understand the strengths and challenges of this design.

Making progress and gaining momentum in global 3Rs efforts: how the European pharmaceutical industry is contributing.

Animal research together with other investigational methods (computer modeling, in vitro tests, etc) remains an indispensable part of the pharmaceutical research and development process. The European pharmaceutical industry recognizes the responsibilities inherent in animal research and is committed to applying and enhancing 3Rs principles. New nonsentient, ex vivo, and in vitro methods are developed every day and contribute to reducing and, in some instances, replacing in vivo studies.

Genetic toxicity assessment: employing the best science for human safety evaluation part IV: a strategy in genotoxicity testing in drug development: some examples.

The minimal three-test battery of the International Conference on Harmonization guideline has been in use since 1997 for the development of new pharmaceuticals (ICH, 1997). After a 10-year experience of this core battery in regulatory genotoxicity testing, everywhere the time has come for reflection about what was learned from this experience. Different aspects of genotoxicity testing are currently being debated under different organizations (HESI, 2006; IWGT, 2007; Kirkland et al.